Drapes are used during surgical procedures, in part, to provide a sterile field about the surgical site and during other treatment procedures requiring the maintenance of a sterile environment. When used during surgery, drapes prevent blood and other bodily fluids from cross contaminating the sterile field.
A variety of surgical drapes exist, but most share several common features. Surgical drapes will have one or more openings or apertures (more commonly known in the medical field as "fenestrations") through which the surgical procedure is performed. Most drapes are made of a water-repellent or water-impermeable material, or are coated with such a material, to prevent passage of bodily fluids as well as contaminating microorganisms. Many of today's surgical drapes are made of disposable nonwoven fabrics, plastic film, or papers.
An adhesive material is normally attached to the periphery of the drape material that defines the fenestration(s) so that the drape can be held in place around the surgical site and so that blood will not pass between the drape and the patient's body. The combination of the drape itself and the adhesive material around the perimeter of the aperture ensures a barrier between the surgical wound and the remainder of the body.
During surgical procedures, fairly large amounts of bodily fluids or irrigation liquids are emitted from the fenestrated operating site. If such fluids were allowed to spill over onto the surgical room floor, potentially hazardous slipping situations could occur. In addition, failure to control fluid runoff during surgery could interfere with the sterile field necessary to be maintained during the procedure.
Various means have been developed to absorb, retain and/or collect such fluids. Early surgical procedures often involved the use of absorbent towels to square off the operating site. These towels would in turn act to absorb fluids. Gradually, the designs were improved to include absorbent materials built into the drape itself, including such materials as foam located about the fenestration. When large amounts of fluid were being used or emitted from the incision area, bags and other types of drainage apparatus were employed to channel, collect, or drain the fluids away from the operating site. Examples of such systems can be found in neurological, obstetrical (c-section) and orthopedic (arthroscopy) drapes.
Currently, both disposable non-woven as well as reusable woven surgical drapes are used to create the sterile field for operative procedures. Some drapes employ a primary base sheet in conjunction with a smaller sheet, or pad, that is often made of an absorbent material backed by a liquid impervious film. When used, the reinforcing, absorbent pad is superimposed over the larger base sheet and is often connected thereto with an adhesive. Both the base sheet and the smaller pad have one or more corresponding apertures which define the surgical sites. An example of a surgical drape with a reinforcing, absorbent pad is shown in U.S. Pat. No. 3,902,484 to Winters. If designed correctly, the absorbent area of a surgical drape facilitates cleanup and movement of the patient after the operative procedure.
Various surgical drapes have been developed which employ either an integral or an attachable pouch near the fenestration(s) to collect runoff fluids used or emitted during surgery. For example, U.S. Pat. No. 3,791,382 to Collins shows a drape useful for abdominal surgery where pouches are mounted on either side of the incision area. U.S. Pat. No. 4,089,331 to Hartigan et al. employs a drape with certain fold-back portions that form pockets near the drape fenestration. These pockets are formed on the drape for retaining fluid runoff emanating from the incision site. U.S. Pat. Nos. 3,364,928, 4,076,017, and 4,570,628 to Creager. Jr., et al., Haswell, and Neal, respectively, show the use of various fluid collection devices on drapes employed for performing various vaginal procedures. The collection devices described in these patents are typically plastic bag-like structures that are either formed integrally with, or attached separately to, the top surface of the surgical drape. U.S. Pat. No. 5,464,024 to Mills et al. illustrates another form of a collection pouch that, in some embodiments, is formed on the top surface of the surgical drape so as to completely surround the fenestration and incision site.
Finally, U.S. Pat. No. 5,618,278 to Rothrum, is illustrative of a surgical drape that employs an attachable fluid collection pouch. As shown in the figures of this patent, a collection pouch is provided with an adhesive attachment means for mounting on the top surface of a surgical drape near the fenestration. The plastic pouch has adhesive mounting strips located on its rear surface which, when release material strips covering the adhesive areas are removed, allow the pouch to be adhered to the cloth-like top surface of the surgical drape.
Problems with the adhesive attachments between plastic fluid collection pouches and the top surface of the surgical drapes are sometimes encountered when using such attachable collection pouch devices. As described above, large amounts of fluids may be used near or emitted from the surgical incision site. Often, the fluids will come into contact with the adhesive interface between the fluid collection pouch and the cloth-like absorbent top surface of the surgical drape. (Generally, the collection pouches will actually be mounted on the absorbent reinforcement pads that are mounted on the larger main panel of the surgical drape.) When this occurs, the adhesive bond between the pouch and the cloth-like surface tends to weaken and sometimes may even fail. Obviously, as the collection pouch becomes heavier due to it filling with liquids, more strength is required at the adhesive interface. If the interface completely fails, the potential exists for the pouch to disconnect from the drape and spill over onto the operating floor or otherwise destroy the sterile field.
Thus, there is still a need for further improved surgical drape designs that employ attachable fluid collection pouches. More specifically, there is a need to improve the adhesive interface between such pouches and the drape surface.